(197 days)
No
The description focuses on standard TENS technology and a heat function, with no mention of AI, ML, or any adaptive or learning algorithms. The performance studies listed are standard for electrical stimulation devices and do not indicate AI/ML components.
Yes
The device is clearly indicated for therapeutic purposes, as it is designed for "temporary relief of pain associated with sore and aching muscles" and "temporarily relieve minor aches and pains," functioning as a TENS device which is a recognized therapeutic modality.
No
Explanation: This device is described as a TENS device used for pain relief, not for identifying or diagnosing a medical condition. Its intended use is for "temporary relief of pain" and "temporarily relieve minor aches and pains," which are therapeutic functions. While a general practitioner may recommend its use, the device itself does not perform diagnostic functions.
No
The device description explicitly states it is a "self-adhesive TENS device with a remote controller" and mentions "gel pads" and "electrical currents," indicating it is a physical hardware device that delivers electrical stimulation and heat. The performance studies also include tests for electrical safety, electromagnetic compatibility, and output waveform validation, which are relevant to hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a TENS (Transcutaneous Electrical Nerve Stimulation) device that applies electrical currents to the skin for pain relief. It also has a heat function.
- Intended Use: The intended use is for temporary relief of pain associated with sore and aching muscles. This is a therapeutic function, not a diagnostic one.
The device operates externally on the body and does not analyze biological samples. Therefore, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.
This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.
Product codes
NUH, IRT
Device Description
The FT-810R with a remote controller is a self-adhesive TENS device with 15 adjustable intensity level for pain relief. Moreover, it also provides a heat function which can be used in conjunction with the TENS function. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective non-pharmacological method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS self-treatment regime.
TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear and must be replaced when they stop providing sufficient contact or the main device no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, upper extremities (leg), upper extremities (arm), lower extremities (leg)
Indicated Patient Age Range
adult
Intended User / Care Setting
home used device
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No clinical test data was used to support the decision of substantial equivalence. A series of safety and performance tests including Shelf life (ASTM F1980-16), Biocompatibility (ISO 10993-1 Edition 5.0, ISO 10993-5 Edition 3.0 and ISO 10993-10 Edition 3.0), Software validation (IEC 62304 Edition 1.1), Electromagnetic compatibility and electrical safety (ANSI/AAMI ES60601-1:2015/(R)2012, IEC 60601-1-2 Edition 4.0, IEC 60601-1-11 Edition 2.0 and IEC 60601-2-10 Edition 2.1), Function test (Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 9, 1999), Usability test (IEC 60601-1-6 Edition 3.2 and IEC 62366-1 Edition 1.1), Function Validation (Attachment 19-1 Performance Verification Report), Output Waveform Validation (Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 8, 1999, Attachment 19-3 Output Waveform Report), and Impedance Validation (Attachment 19-4 Impedance Test Report) were conducted. All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 13, 2023
Hivox Biotek Inc. Shaun Hsu Regulatory Affairs Specialist 5F., No. 123, Xingde Rd. Sanchong Dist. New Taipei City, 24158 Taiwan
Re: K223308
Trade/Device Name: Heating Tens/ems, Ft-810r Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, IRT Dated: January 17, 2023 Received: April 14, 2023
Dear Shaun Hsu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela D. Scott -S
Pamela D. Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K223308
Device Name Heating TENS (FT-810R)
Indications for Use (Describe)
This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
1. Type of Submission Traditional
| 2. Date of Summary | October 21, 2022 |
|---|---|
| 3. Submitter | HIVOX BIOTEK INC. |
| Address: | 5F., No. 123, Xingde Rd., Sanchong Dist., |
| New Taipei City 24158, Taiwan, R.O.C. | |
| Phone: | +886-2-8511-2668 |
| Fax: | +886-2-8511-2669 |
| Contact: | Shaun Hsu (shaun.hsu@hivox-biotek.com) |
4. Identification of the Subject Device
| Proprietary Name: | Heating TENS |
|---|---|
| Model: | FT-810R |
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH |
| Regulation Number: | 21 CFR 882.5890 |
| Device Class: | II |
5. Identification of the Predicate Device #1
| 510(k) Number: | K203574 |
|---|---|
| Manufacturer: | HIVOX BIOTEK INC. |
| Proprietary Name: | HIVOX OTC Electrical Stimulator |
| Model: | EM59-1 |
| Regulatory Description: | 1) Transcutaneous electrical nerve stimulator for pain relief |
- Power heating pad |
| Product Code: | NUH, IRT |
| Regulatory Number: | 1) 21 CFR 882.5890 - 21 CFR 890.5740 |
| Device Class: | II |
6. Identification of the Predicate Device #2
| 510(k) Number: | K211403 |
|---|---|
| Manufacturer: | HIVOX BIOTEK INC. |
| Proprietary Name: | HIVOX OTC Electrical Stimulator |
| Model: | FT610-B |
| Regulatory Description: | Transcutaneous electrical nerve stimulator for pain relie |
| Product Code: | NUH |
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Regulatory Number: 21 CFR 882.5890 Device Class: II
7. Identification of the Reference Device
| 510(k) Number: | K163393 |
|---|---|
| Manufacturer: | Hi-Dow International, Inc. |
| Proprietary Name: | Hi-Dow Wireless TENS/EMS |
| Model: | HD-5N |
| Regulatory Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH, NGX |
| Regulatory Number: | 21 CFR 882.5890 |
| Device Class: | II |
8. Device Description
The FT-810R with a remote controller is a self-adhesive TENS device with 15 adjustable intensity level for pain relief. Moreover, it also provides a heat function which can be used in conjunction with the TENS function. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective non-pharmacological method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS self-treatment regime.
TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear and must be replaced when they stop providing sufficient contact or the main device no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.
9. Intended Use / Indications for Use of the Device
This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.
10. Non-clinical Testing
A series of safety and performance tests, as follows, were conducted on the subject
5
device in accordance with FDA recognized consensus standards and/or guidance:
- Shelf life (ASTM F1980-16)
- Biocompatibility (ISO 10993-1 Edition 5.0, ISO 10993-5 Edition 3.0 and ISO 10993-10 Edition 3.0)
- Software validation (IEC 62304 Edition 1.1)
- Electromagnetic compatibility and electrical safety (ANSI/AAMI ES60601-1:2015/(R)2012, IEC 60601-1-2 Edition 4.0, IEC 60601-1-11 Edition 2.0 and IEC 60601-2-10 Edition 2.1)
- Function test (Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 9, 1999)
- Usability test (IEC 60601-1-6 Edition 3.2 and IEC 62366-1 Edition 1.1)
- Function Validation (Attachment 19-1 Performance Verification Report)
- Output Waveform Validation (Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 8, 1999, Attachment 19-3 Output Waveform Report)
- Impedance Validation (Attachment 19-4 Impedance Test Report)
All the test results demonstrate the subject device, Heating TENS (FT-810R), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device.
11. Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
12. Substantial Equivalence Comparison
The subject device, Heating TENS (FT-810R), was compared to the predicate devices and reference device in the table below:
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Traditional 510(k) Section 6 – 510(k) Summary
Table 1 – Comparison to Predicate Devices and Reference Device
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Reference device | Substantial
Equivalence Determination |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K223308 | K203574 | K211403 | K163393 | |
| Device Name | Heating TENS | HIVOX OTC Electrical
Stimulator | HIVOX OTC Electrical
Stimulator | Hi-Dow Wireless
TENS/EMS | N/A |
| Model | FT-810R | EM59-1 | FT610-B | HD-5N | |
| Manufacturer | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | Hi-Dow International, Inc. | |
| Intended Use | This home used device is
designed to be used for adult and
for temporary relief of pain
associated with sore and aching
muscles in the shoulder, waist,
back, upper extremities (arm) and
lower extremities (leg) due to
strain from exercise or normal
household work activities. In
addition, it also provides a heat
function intended to temporarily
relief of minor aches and pains. | EM59-1:
TENS: This function is designed to be used for temporary relief of
pain associated with sore and aching muscles in the shoulder,
waist, back, upper extremities (arm) and lower extremities (leg)
due to strain from exercise or normal household work activities.
SH: This function is designed to be used for temporary relief of
minor aches and pains. | The FT610-B is designed
for symptomatic relief and
management of chronic
pain, and for temporary
relief of pain associated
with sore and aching
muscles in the shoulder,
waist, back, neck, upper
extremities and lower
extremities due to strain
from exercise or normal
household work activities. | TENS:
To be used for the
temporary relief of pain
associated with sore or
aching muscles in the
shoulder, waist, back,
upper extremities (arm),
and lower extremities (leg)
due to strain from exercise
or normal household work
activities.
EMS:
It is intended for muscle
conditioning, used for
stimulating muscles
including abdomen muscles
in order to improve or
facilitate muscle
performance. | Subject device implements the same
technological features as the predicate
devices.
We are using the FT610-B to show that
FDA has cleared a TENS with heating
capability for the same indication for us
that we are seeking for the FT-810R that
has maximum charge per phase of 7.2 $\mu$
which is lower than the maximum
charge per phase of the 810R. The
primary predicate (predicate # 1) has a
maximum charger per phase of 45 $\mu$ and
has a heating capability and an
indication for use that is identical to
which you are seeking for the 810R.
Therefore, because the maximum charge
per phase of the 810R falls between the
charge per phase of the 610-B and the
EM59-1 and the 810R has the same
indication for use as the two predicates,
The FT-810R is substantially equivalent
to the legally marketed predicate.
Additionally, reference device used for
addition of wireless. |
| FDA Product Code | NUH | NUH, IRT | NUH | NUH, NGX | Identical to predicate device #2 |
| Prescription or OTC | OTC | OTC | OTC | OTC | Identical |
| Power Source(s) | 3.7 V Lithium-ion battery | Rechargeable battery | 3.7 V Lithium-ion battery | DC 3.7V Lithium Battery | Identical |
| Function and Design | Electrical stimulation
and heat | Electrical stimulation
and heat | Electrical stimulation
and heat | Electrical stimulation | Identical to predicate device |
| Heating setting | Low and high | Low and high | Nonadjustable | N/A | Predicate device #2 has nonadjustable
heating setting which will stay
continuously 43℃ unless user switch off
the heating function. Hence, the setting
differences would not raise concern in |
7
| | Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Reference device | Substantial
Equivalence Determination | |
|--------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | | | | | | safety or effectiveness from predicate
device | |
| | Maximum Temperature Setting
(°C) | 43 | 43 | 43 | N/A | Identical to predicate device | |
| | Output Pattern of the Heating | Delivers electrical
stimulation and heat
simultaneously | · Electrical stimulation only
· Heat only
· Electrical stimulation + Heat simultaneously | Delivers electrical
stimulation and heat
simultaneously | N/A | Identical to predicate device | |
| | Method of Line Current
Isolation | N/A
(internal power source) | N/A
(internal power source) | N/A
(internal power source) | Two separate devices, and
use independent power
supply system. | Identical to predicate device | |
| | Patient
Leakage
Current | Normal
Condition (μΑ) |